This double-blind, placebo-controlled trial enrolled normal healthy adult volunteers in sequential, dose-escalating cohorts. The Phase I data show that single, oral doses of NGX426 from 40mg to 90mg are safe and well-tolerated. TorreyPines Therapeutics is amending the Phase I clinical trial protocol to extend the dosing range beyond 90mg to identify the maximum tolerated dose.
With the recently demonstrated efficacy of 40mg of tezampanel in a Phase IIb clinical trial in acute migraine, the comparable area under the curve (AUCs) suggest that NGX426 also may be effective in treating acute migraine headache. TorreyPines plans to initiate a Phase IIa study of NGX426 in acute migraine in the first half of 2008.
Tezampanel is the first AMPA/kainate antagonist to be studied in a clinical trial for acute migraine. Tezampanel, by blocking the binding of glutamate to these receptors, is believed to inhibit the transmission of pain signals that lead to migraine headaches.
Neil Kurtz, president and CEO of TorreyPines, said: “These data fully support the continued development of NGX426, which, as an oral prodrug, can provide an additional route of administration for tezampanel to acute migraine sufferers.”